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Device detects brain injury without surgery

Bill Cary, wcary@lohud.com 12:17 a.m. EDT July 29, 2014

A revolutionary non-surgical way to diagnosis and measure traumatic brain injury, which has the potential to save thousands of lives, has been developed by a team led by Arthur Rappaport of Pound Ridge.

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Arthur Rappaport, inventor of a non-invasive device to measure for traumatic brain injury, is photographed July 8 at his home in Pound Ridge. The device has a probe and measures pressure inside the brain.(Photo: Tania Savayan/The Journal News)Buy Photo

After nearly 10 years in development, Arthur Rappaport's revolutionary new medical device — a non-surgical way to diagnosis and measure traumatic brain injury — is within 18 months of coming to market.

It has the potential of saving thousands of lives, in hospital and ambulance settings as well as on the battlefield and suburban football field.

Rappaport, a longtime Pound Ridge resident with 35 years of international experience as an entrepreneur (fast food, fashion and entertainment), became interested in the project after a fairly miraculous surgical intervention that cured his metastatic prostate cancer a decade ago.

"I was drawn to the project because I was a recent cancer survivor looking to make a difference in other people's lives as a result of medical science saving my life," says Rappaport, whose stunning glass, steel and stone home was recently featured in the Living Here section of The Journal News/lohud.com.

To help us learn more about the project, we asked Rappaport to sit down for a Q&A.

Describe the device and how it works.

Current intracranial pressure (ICP) monitoring methods require surgical insertion of a measuring device beneath the skull. This device is a portable real-time ultrasound instrument that can measure ICP in traumatic brain injuries and pathological brain conditions. With a 1-inch diameter ultrasound probe on the patient's forehead, it targets brain soft tissue stimulated by specific ultrasound signals. The reflected ultrasound energy waves bounce back from the tissue with information on its elasticity. The collected data is interpreted through mathematical algorithms from the device's database, which is compiled with data from clinical gold-standard invasive measurements. The results provide quantitative information about the physiological state of the brain tissue, indicating if a traumatic brain injury has occurred.

What stage is it in, and when might it hit the market?

Our final prototype has been successfully tested in a clinical trial involving patients in the neuro intensive care unit at Columbia University Medical Center/New York Presbyterian Hospital in New York City. A "Proof of Principle" of the device's performance has been established with results from our device being compared and positively correlated to the present gold standard, an invasive device. Our next step is to take our prototype and conform it to the standards of the U.S. Food and Drug Administration as a designed commercial medical device and go through the specific testing requirements instituted by the FDA. We expect the device to hit the market in 18 months, assuming funding is available.

Who will benefit from it? Where will it be used?

The technology allows the diagnosis of elevated ICP to be made at the scene of the injury. Elevated ICP can lead to cerebral ischemia and possible destruction of brain tissue, placing the patient at risk of incurring chronically debilitating and potentially lethal brain damage. This avoids a delay in ICP assessment in patients potentially at risk until signs of neurological dysfunction develop. With a non-invasive assessment, you don't need to wait for signs of elevated ICP to become evident and you don't have to get the patient to a hospital. A neurosurgeon would not be needed to implant a device and the tests could be conducted in many non-hospital locations (scene of an accident, ambulance and air transport, sports field, battlefield, emergency rooms, urgent care centers, nursing homes).

Is there anything else like it available now?

At present there is no non-invasive device available in the U.S., European Union, Japan, or any other First World country. Today, there is significant research attempting to solve this problem, but no company or group in the world has reached the stage where we are. Our accuracy and precision far exceeds anything accomplished by competition in attempting to find an effective solution.